Head of Analytical Development

Job Summary

Seeking a highly skilled Head of Analytical Development, this full-time remote position will manage the analytical function, leading teams in the development of integrated analytical control strategies for drug substances and inhaled drug products, while ensuring compliance with regulatory guidelines and readiness for NDA submissions.

Key responsibilities

• Lead the analytical development function, mentoring team leads and scientists across drug substance and drug product
• Own and implement the integrated analytical control strategy, ensuring alignment with regulatory guidelines
• Oversee analytical activities for inhalation products, including method development, validation, and stability programs across multiple sites

Required qualifications

• PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, with 15+ years of pharmaceutical industry experience
• 8+ years of leadership experience in analytical chemistry, managing teams and functions related to drug substance and inhaled drug products
• Demonstrated experience leading analytical activities through NDA/MAA submission and pre-approval inspections
• Deep expertise in solid-state and particle characterization techniques relevant to drug development
• Strong strategic and collaboration skills, with the ability to manage timelines and budgets effectively